Phase II clinical trial for recurrent high-grade meningioma
First written in FY2021. 10 of 22 entries say "Restated". Latest entry: 2026-10-22.
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- FY2026AdvancedAnnual report
「For progression-free survival, the trial's primary endpoint based on assessment by an independent review organization, the trial treatment group recorded 14.4 months (95% confidence interval: 7.93-26.8), compared with 1.4 months for the control group (95% confidence interval: 0.93-9.13), representing a statistically significant difference (p=0.0157, Log-rank test). Based on these favorable results, in March 2026 the Company filed an application with the Ministry of Health, Labour and Welfare for a partial change to the approved marketing authorization for recurrent meningioma.」
The Phase II trial for recurrent high-grade meningioma confirmed a statistically significant difference in progression-free survival and filed an application for a partial change in March 2026. - FY2026-H1AdvancedAnnual report
「For progression-free survival, the trial's primary endpoint based on assessment by an independent review organization, the trial treatment group recorded 14.4 months (95% confidence interval: 7.93-26.8), compared with 1.4 months for the control group (95% confidence interval: 0.93-9.13), representing a statistically significant difference (p=0.0157, Log-rank test).」
The Phase II trial for recurrent high-grade meningioma confirmed a statistically significant difference in progression-free survival between the treatment and control groups and moved to the discussion phase toward filing for approval in the fiscal year ending March 2026. - FY2025AdvancedAnnual report
「A presentation on the results of the physician-initiated Phase II clinical trial of BNCT for recurrent high-grade meningioma using borofalan (10B), a boron drug being developed by the Company (development code: SPM-011), has been accepted for a poster session at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held in Chicago, Illinois, U.S., from 30 May to 3 June 2025.」
A presentation on the results of the Phase II trial for recurrent high-grade meningioma was accepted for a poster session at the ASCO 2025 Annual Meeting. - FY2025-H1AdvancedAnnual report
「Subject enrollment for the trial was completed in September 2021, and observation of all subjects for the primary endpoint was completed in February 2024. Assessment, data analysis and other activities are scheduled to be conducted going forward. After carefully assessing the trial results, discussions with the PMDA toward filing an application will begin.」
For the Phase II trial for recurrent high-grade meningioma, observation of all subjects for the primary endpoint was completed in February 2024, and the trial has entered the phase of assessment, data analysis and discussions with the PMDA regarding an application. - FY2024-Q3RestatedAnnual report
「A physician-initiated Phase II clinical trial is being conducted at Osaka Medical and Pharmaceutical University Hospital, and subject enrollment for the trial was completed in September 2021. Going forward, assessment, data analysis and other activities are scheduled to be conducted following a follow-up period of up to 3 years for the subjects, after which discussions with the PMDA toward filing an application will begin.」
The plan for follow-up, assessment and data analysis for up to 3 years after completion of enrollment in the Phase II trial for recurrent high-grade meningioma, followed by discussions with the PMDA after completion of the trial, continues. - FY2024-Q2RestatedAnnual report
「A physician-initiated Phase II clinical trial is being conducted at Osaka Medical and Pharmaceutical University Hospital, and subject enrollment for the trial was completed in September 2021. Going forward, assessment, data analysis and other activities are scheduled to be conducted following a follow-up period of up to 3 years for the subjects, after which discussions with the PMDA toward filing an application will begin.」
The plan for follow-up, assessment and data analysis for up to 3 years after completion of enrollment in the Phase II trial for recurrent high-grade meningioma, followed by discussions with the PMDA after completion of the trial, continues. - FY2024-Q1RestatedAnnual report
「Going forward, assessment, data analysis and other activities are scheduled to be conducted following a follow-up period of up to 3 years for the subjects, after which discussions with the PMDA toward filing an application will begin.」
The plan for follow-up, assessment and data analysis for up to 3 years after completion of enrollment in the Phase II trial for recurrent high-grade meningioma, followed by discussions with the PMDA after completion of the trial, continues. - FY2023-Q3RestatedAnnual report
「Going forward, assessment, data analysis and other activities are scheduled to be conducted following a follow-up period of up to 3 years for the subjects.」
The plan for follow-up, assessment and data analysis for up to 3 years after completion of enrollment in the Phase II trial for recurrent high-grade meningioma continues. - FY2023-Q2RestatedAnnual report
「A Phase II clinical trial is being conducted at Osaka Medical and Pharmaceutical University Hospital as an investigator-initiated clinical trial, and enrollment of subjects in the trial was completed in September 2021. Going forward, evaluations and data analysis are scheduled to be conducted after a follow-up period of up to 3 years for the subjects.」
The plan for follow-up, assessment and data analysis for up to 3 years after completion of enrollment in the Phase II trial for recurrent high-grade meningioma continues. - FY2023-Q1RestatedAnnual report
「A Phase II clinical trial is being conducted at Osaka Medical and Pharmaceutical University Hospital as an investigator-initiated clinical trial, and enrollment of subjects in the trial was completed in September 2021. Going forward, evaluations and data analysis are scheduled to be conducted after a follow-up period of up to 3 years for the subjects.」
The plan for follow-up, assessment and data analysis for up to 3 years after completion of enrollment in the Phase II trial for recurrent high-grade meningioma continues. - FY2022RestatedAnnual report
「A physician-initiated Phase II clinical trial is being conducted at Osaka Medical and Pharmaceutical University Hospital, and subject enrollment for the trial was completed in September 2021. Going forward, assessment, data analysis and other activities are scheduled to be conducted following a follow-up period of up to 3 years for the subjects.」
The plan to conduct follow-up, assessment and data analysis for up to 3 years after completion of subject enrollment continues. - FY2022-Q3RestatedAnnual report
「A Phase II clinical trial is being conducted at Osaka Medical and Pharmaceutical University Hospital as an investigator-initiated clinical trial, and enrollment of subjects in the trial was completed in September 2021. Going forward, evaluations and data analysis are scheduled to be conducted after a follow-up period of up to 3 years for the subjects.」
The established phase of follow-up for up to 3 years after completion of subject enrollment, assessment and data analysis continues to be described. - FY2022-Q2AdvancedAnnual report
「A Phase II clinical trial is being conducted at Osaka Medical and Pharmaceutical University Hospital as an investigator-initiated clinical trial, and enrollment of subjects in the trial was completed in September 2021. Going forward, evaluations and data analysis are scheduled to be conducted after a follow-up period of up to 3 years for the subjects.」
Subject enrollment in the Phase II trial for recurrent high-grade meningioma has been completed, and the study has moved to the follow-up and assessment phase, lasting up to 3 years. - FY2022-Q1RestatedAnnual report
「A Phase II clinical trial is being conducted at Osaka Medical and Pharmaceutical University Hospital as an investigator-initiated clinical trial, and we are providing the investigational drug used in the trial.」
The Phase II investigator-initiated clinical trial for recurrent high-grade meningioma and provision of the investigational drug are continuing. - FY2021First statedAnnual report
「As a new pipeline program, a Phase II clinical trial is being conducted at Osaka Medical and Pharmaceutical University Hospital as an investigator-initiated clinical trial for recurrent high-grade meningioma, a type of brain tumour. We are providing the investigational drug used in this trial.」
An investigator-initiated clinical trial is being conducted as a new pipeline program, and the investigational drug is being provided.